RE: Med-technews full web link5 Jan 2022 16:14
Not the same as for sale in Boots though. HUA is a prerequisite and one element for approval. The desktop/CTDA still needs to be processed and in the EU believe the Health and Security Committee are the arbitrers and Meduflow does not appear there yet https://ec.europa.eu/health/sites/default/files/preparedness_response/docs/covid-19_rat_common-list_en.pdf :
"While the reverse transcription real-time polymerase chain reaction (RT-PCR) assay, which is
a nucleic acid amplification test (NAAT), remains the ‘gold standard’ for COVID-19
diagnosis, rapid antigen tests, which detect the presence of viral proteins (antigens), are
increasingly being used by Member States as a way of further strengthening countries’ overall
testing capacity, particularly in case of limited NAAT capacities or where prolonged testing
turnaround times results in no clinical utility.
The Health Security Committee (HSC) agreed on 17 September 2020 on Recommendations
for a common EU testing approach for COVID-191
, setting out various actions for
consideration by countries when updating or adapting their testing strategies. The
Recommendations included Member States’ first experiences with rapid antigen tests and
their deliberations concerning the settings and situations in which these tests should be used.
Since then, the HSC has been discussing the use and application of rapid antigen tests in great
depth, and has brought together a wealth of (technical) information on the types of tests used
in European countries and the conditions applied.
On 21 January 2021, Member States unanimously agreed on a Council Recommendation
setting a common framework for the use of rapid antigen tests and the mutual recognition of
COVID-19 test results across the EU
. The Council Recommendation called on Member
States to agree on three concrete deliverables:
1. A common list of COVID-19 rapid antigen tests "
I think the EU do apply real life samples to the process so expect approval and retail there first until UK change from bad science.